Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
As a Director, Quantitative Pharmacology, Pharmacometrics you will play a critical role in advancing drug development by serving as the key expert on all pharmacometrics matters relating to assigned clinical projects. You will oversee all pharmacometrics activities related to pre-IND, IND, phase 1-3, PK, PK/PD and regulatory submissions.
In this position, you will lead analysis, execution and reporting of pharmacometrics studies. You will provide input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response and pediatric development. The Director of Quantitative Pharmacology, Pharmacometrics loosely interacts with non-clinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies.
This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs. Remote options will be considered for US candidates.
Job Description:
- Author/reviewer of clinical pharmacology and pharmacometrics submission documents and representative of the department at different product development team meetings.
- Interacts with early development and business development team members as well as external collaborators to assess/lead development and selection of pre-IND and early phase assets.
- Lead pharmacometrics activities related to study design, protocol development, study execution, reporting and interpretation of data.
- Conduct population PK, PK/PD analysis and modeling and simulation.
- Leads pharmacometrics team members and participate in activities related to analysis and reporting of population PK and PK/PD analyses.
- Leads pharmacometrics and modeling and simulation activities to support optimizing clinical study dose, dosing regimen and design.
- Lead development of pharmacometrics sections of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications and pediatrics development plans.
- Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK and PK/PD.
- Work with formulation development groups and provide support for activities related to formulation development, dissolution testing, in vivo-in vitro correlations and biowaivers for pre- and post-approval formulations.
- Manage pharmacometrics activities related to project budgets, outsourcing of PK and PK/PD analyses, contract requisition, SOW and approval of invoices.
- Training and mentoring of staff related to population PK and PK/PD modeling.
- Serve as pharmacometrics lead on multiple project teams and as a team member on other key projects as needed and lead model-based drug development strategies for ongoing projects.
Minimum Qualifications:
- PhD in pharmacometrics (or a related area such as pharmacokinetics, clinical pharmacology, pharmacology, or a related area) with a minimum of 8-10 years of industry experience in these areas.
- Strong technical and hands on experience in population PK and PK/PD modeling.
- In-depth knowledge of pharmacometrics, population PK and PK/PD modeling, clinical pharmacology, drug metabolism, biopharmaceutics, and bioanalytical chemistry.
- Hands-on PK and PK/PD analysis and statistical analysis using NonMEM, Phoenix NLME, Julia, R etc.
- Excellent working knowledge of phase I clinical operations, drug development, multi-region regulatory requirements.
- Good working knowledge of formulation development, drug development and clinical development.
- Current awareness of the latest developments in clinical pharmacology and guidance documents.
- Must be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
- Strong technical and hands-on experience related to pharmacometrics, population PK and PK/PD modeling.
Our Benefits:
- Comprehensive medical, dental, vision and prescription drug coverage
- Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance.
- Tuition reimbursement
- 401(k) match
- PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
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